A Multiple Health Behavior Change Internet Program for College Students
Primary Purpose
Sedentary Lifestyle, Stress, Psychological, Healthy Eating
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
liveWell: A healthy foundation for life
Sponsored by
About this trial
This is an interventional prevention trial for Sedentary Lifestyle
Eligibility Criteria
Inclusion Criteria:
- enrolled as a freshmen in college
- English speaking
Exclusion Criteria:
-
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
liveWell: A healthy foundation for life
Arm Description
Outcomes
Primary Outcome Measures
Change from Baseline in Adoption of Healthy Eating at 6 & 12 months
Continuous measure of fruit and vegetable intake: stage of readiness for fruit and vegetable intake.
Change from Baseline in Adoption of Exercise at 6 & 12 months
Godin Leisure Time Exercise Questionnaire and stage of readiness for regular exercise
Triaxial accelerometers in sub-sample of participants
Change from Baseline in Adoption of Exercise, Healthy Eating, and Effective Change from Baseline in Adoption of Effective Stress Management at 6 & 12 months
RISCI: Rhode Island Stress and Coping Inventory and stage of readiness for effective stress management
Secondary Outcome Measures
Full Information
NCT ID
NCT01555203
First Posted
August 15, 2011
Last Updated
April 27, 2015
Sponsor
Pro-Change Behavior Systems
1. Study Identification
Unique Protocol Identification Number
NCT01555203
Brief Title
A Multiple Health Behavior Change Internet Program for College Students
Official Title
A Multiple Health Behavior Change Internet Program for College Students
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pro-Change Behavior Systems
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this Phase II research is to evaluate the effectiveness of a population-based, individually tailored multiple health behavior change program for exercise, healthy eating, and stress management in a randomized trial including approximately 1,500 college students.
Detailed Description
Despite the importance of shaping a solid foundation of health behaviors early in life, college students have been understudied as a population for health promotion programs. This study represents innovative research for impacting the promotion of healthy lifestyles among college students. The objective is to develop and test a population-based, multiple health behavior change program for college students, liveWell: A Healthy Foundation for Life.
The multiple behavior multimedia program will offer Transtheoretical Model-based (TTM) computer tailored feedback on regular exercise, fruit and vegetable consumption, and effective stress management, as well as providing access to a stage-matched dynamic web portal. The TTM is a comprehensive model that integrates ideas from several different theories and approaches to change (hence the name "Transtheoretical") to explain and predict how and when individuals end high-risk behaviors or adopt healthy ones. Thirty years of research has consistently demonstrated that change is a process that unfolds over time through a series of stages: Precontemplation, Contemplation, Preparation, Action, and Maintenance. It matches specific principles and processes of change to each person's stage of change and guides individuals through the change process. The TTM has been applied throughout the world to behaviors such as smoking cessation, alcohol reduction, bullying prevention, weight management, and medication adherence.
A primary goal of this Phase II grant is to assess the effectiveness of liveWell in a randomized trial including 1680 students from 2 large universities in the U.S. Students will be recruited via freshman orientation classes and will complete follow-up assessments at 6-and 12-months. Effectiveness will be assessed by comparing improvements in continuous outcome measures and movement to public health criteria for each behavior. This intervention offers a cost-effective, science-based, and easily deliverable solution to improve multiple health behaviors, and overall health and well-being, of college students.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sedentary Lifestyle, Stress, Psychological, Healthy Eating
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1877 (Actual)
8. Arms, Groups, and Interventions
Arm Title
liveWell: A healthy foundation for life
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
liveWell: A healthy foundation for life
Intervention Description
liveWell is a unique online, mobile-compatible, multi-media, evidence-based program designed to help college students exercise, eat healthy, and manage stress. At the core of the Transtheoretical Model-based intervention is a computer-tailored behavior change intervention (CTI) that analyzes students' responses to reliable and valid assessments of key behavior change constructs using empirically derived pre-programmed decision rules. The rules determine which feedback users receive on how they are doing compared to their peers in their same stage. At follow-up, feedback is further tailored to how students are doing compared to their last session.
In addition to the CTI, completed three times during the semester, liveWell includes a dynamic portal that is populated with a variety of engaging and interactive stage-matched activities and resources. The portal provides more content and specifics on how to apply each of the processes and principles of change introduced in the CTI.
Primary Outcome Measure Information:
Title
Change from Baseline in Adoption of Healthy Eating at 6 & 12 months
Description
Continuous measure of fruit and vegetable intake: stage of readiness for fruit and vegetable intake.
Time Frame
Baseline, six months and twelve months
Title
Change from Baseline in Adoption of Exercise at 6 & 12 months
Description
Godin Leisure Time Exercise Questionnaire and stage of readiness for regular exercise
Triaxial accelerometers in sub-sample of participants
Time Frame
Baseline, six months and twelve months
Title
Change from Baseline in Adoption of Exercise, Healthy Eating, and Effective Change from Baseline in Adoption of Effective Stress Management at 6 & 12 months
Description
RISCI: Rhode Island Stress and Coping Inventory and stage of readiness for effective stress management
Time Frame
Baseline, six months and twelve months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
enrolled as a freshmen in college
English speaking
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Johnson, PhD
Organizational Affiliation
Pro-Change Behavior Systems, Inc.
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
A Multiple Health Behavior Change Internet Program for College Students
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